Common questions about clinical affairs jobs careers in the medical device industry. Jobs are aggregated daily from multiple sources and filtered to this category.
- What does a clinical affairs specialist do in medical devices?
- Clinical affairs specialists manage the clinical evidence lifecycle for medical devices. Key responsibilities include: Clinical Evaluation - Writing and updating Clinical Evaluation Reports (CERs) per MEDDEV 2.7/1 Rev 4, Literature Reviews - Systematic literature searches and appraisals, PMCF - Designing Post-Market Clinical Follow-up studies, Clinical Investigations - Planning and managing clinical trials when needed, Regulatory Submissions - Supporting 510(k), PMA, and technical file submissions with clinical data, KOL Management - Working with clinical advisors and investigators.
- What qualifications are needed for clinical affairs jobs?
- Clinical affairs positions typically require: Education: Master's or PhD in life sciences, nursing, or clinical research preferred. Bachelor's with strong experience considered. Experience: 3-5 years for specialist, 7-10+ years for director roles. Skills: Scientific writing, literature review methodology, statistical analysis, regulatory knowledge (FDA, EU MDR). Knowledge: MEDDEV 2.7/1 Rev 4, ISO 14155, GCP, clinical trial design. Background: Many come from clinical research, nursing, or scientific writing roles.
- What is a Clinical Evaluation Report (CER) and why is it important?
- A CER is a comprehensive document demonstrating clinical safety and performance of a medical device. Required for: EU MDR - Mandatory for all devices, must be updated throughout lifecycle, UK UKCA - Similar requirements under UK MDR. CER components include: Literature review - Systematic analysis of published evidence, Clinical data appraisal - Assessment of pre-clinical and clinical studies, Risk-benefit analysis - Demonstrating favorable benefit-risk ratio, PMCF plan - Ongoing data collection strategy. CER expertise is in extremely high demand due to EU MDR transition.
